Resistance to Fecal Transplants as Treatment for C. diff. Infection

One of the worst infections you can get in a hospital is C. difficile. It is notoriously unpleasant and hard to get rid of. It has recently been discovered that fecal transplants are highly effective against this infection. Here’s what happened next:

The Food & Drug Administration (FDA) [decided] to require an Investigational New Drug (IND) application for stool transplants—formally known as “fecal microbiota transplants (FMT)”—for the treatment of C. difficile colitis. “C. diff,” as it is known, is a severe inflammation of the bowel . . .

Over the last 10 years of my practice, I saw a change in the patients I treated for C. diff. More patients were affected, they were generally more severely ill, and the infection became increasingly difficult to treat. . . . often being refractory to therapy. . . . I also began to see patients floridly septic from C. diff, occasionally needing emergency surgery to remove their colon (colectomy). [I began] to wonder whether we shouldn’t be treating severe cases of acute C. diff with stool transplants. I reasoned that it was a better alternative to an emergency colectomy. . . .

There are barriers to doing so, however:

First, there is the “ick” factor. Thus far, resistance to transplants I have recommended has not come from patients or their families, who are desperate for relief. It has come from other health care workers, especially physicians, who seem to find the idea particularly distasteful. [emphasis added. This article supports the idea that doctors are a major source of resistance to this treatment.]

There is cost and time—while the “medicine” is inexpensive and readily available, current recommendations are that the stool donor be tested for a variety of infectious diseases at a cost of $1500-2000. There might be a week’s delay, while the donor is tested for hepatitis and other infections. . . . And now there is the new FDA requirement for an IND, which will be the coup de grace for this treatment. . . . INDs are incredibly burdensome, time-consuming, and expensive for an independent practitioner to obtain. They involve hours of paperwork (my office practice consisted of me and 1-1.5 secretaries; who has time?).

Given the awfulness and danger of this infection, I think it is fair to say that the home-treatment approach (via enema) is very easy. The author of this post, Dr. Judy Stone, complains about home treatment:

Then the sole data will come from some ambitious citizen science group [which is terrible because . . . ? — Seth], and acutely or seriously ill hospitalized patients, too ill to be treated at home, will be deprived of potentially life-saving treatment.

Dr. Stone is serious — deadly serious, you could say. According to this article, “more than 9% of C. diff-related hospitalizations end in death.” Fecal transplants are very effective. Stone predicts that patients will die because “hours of paperwork” are too much trouble, at least for her (“who has time?”). A more persuasive article would have explained why patients who need this treatment cannot be sent to doctors who decide that “hours of paperwork” are doable if that is what it takes to save lives.

Not everyone responds to the traditional treatment. Yes, it costs to screen the donor but one 10-day supply of Difficid is $3800. Vancomycin is not much cheaper, and doctors are leaving patients on it for months and then we relapse as soon as it is stopped.

Patients with refractory C Diff who have not responded to the antibiotics are going to die, deaths that could have been prevented.

Has anyone talked about the FDA getting pressured by Big Pharma to stop fecal transplants so the drug companies can recoup the monies they have spent on bringing these drugs to market, even though they don’t always work?

Seth says: “You can do the paperwork once for many patients.” I doubt it. This is the government we’re talking about.

David Johnston says: “Perhaps hospitals could seek out people with excellent poop with optimal therapeutic properties and pay them for their poop.” Poop Banks. Give blood and poop at the same time. (Actually not a bad idea…but could you imagine?)